Effects of Seroquel XR on Sleep Architecture in Patients With Major Depressive Disorder

Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder

In this study, patients with major depressive disorder (MDD) who have insomnia symptom are treated with Seroquel XR in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.

Study Overview

• Status: Withdrawn
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Quetiapine Fumarate Extended Release

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ewha Womans University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patient Inclusion Criteria:

• Men and women aged between 20 and 65
• Diagnosis of major depressive disorder as assessed by Structured Clinical Interview for DSM-IV (SCID-IV)
• A score of 1 or greater on any of the sleep items (items 4, 5, 6) from the Hamilton Depression Rating Scale (HDRS)
• Provision of written informed consent

Healthy Control Subject Inclusion Criteria:

• Healthy Men and Women aged between 20 and 65
• Provision of written informed consent

Exclusion Criteria:

• Presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.)
• Diagnosis of any Axis I disorder other than major depressive disorder or presence of symptoms requiring hospitalization
• Drug abuse in past 3 months
• Women who are pregnant，breastfeeding, or planning pregnancy
• Contraindications to drugs used in the study (e.g., allergy, intolerance, etc.)
• Unstable medical illness or severe abnormality in laboratory test at screening assessment
• Increase in blood glucose, lipid, and calcium levels at screening
• Low blood pressure at screening assessment
• Intelligence quotient below 80
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
• Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 3 months prior to enrolment
• Previous enrolment or randomisation of treatment in the present study.
• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• A patient with Diabetes Mellitus
• An absolute neutrophil count (ANC) of <= 1.5 x 10^9 per liter
• Insomnia from other causes of medical or neurological diseases
• Involvement in the planning and conduct of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seroquel XR; Patients with MDD receives Seroquel XR.	Drug: Quetiapine Fumarate Extended Release; Day 1 50mg, Day 2 50mg, Day 3 150mg, Day 4~28 50~150mg (increments and deduction of 50mg are allowed)
No Intervention: healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline Pittsburgh Quality Index total scores at 4 weeks	baseline and 4 weeks
change from baseline Pittsburgh Quality Index total scores at 2 weeks	baseline and 2 weeks
change from baseline Pittsburgh Quality Index total scores at 4 days	baseline and 4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
number of participants with adverse events	4 weeks
change from baseline in sleep architecture measured using polysomnography at 4 weeks	baseline and at 4 weeks
number of participants with adverse events	2 weeks
number of participants with adverse events	4 days

Collaborators and Investigators

• Sponsor: Ewha Womans University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: D1443C00042